Registration Dossier
Registration Dossier
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EC number: 231-272-0 | CAS number: 7473-98-5
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From Jun. 1978 to Mar. 6, 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- -data for single animals not given
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-hydroxy-2-methylpropiophenone
- EC Number:
- 231-272-0
- EC Name:
- 2-hydroxy-2-methylpropiophenone
- Cas Number:
- 7473-98-5
- Molecular formula:
- C10H12O2
- IUPAC Name:
- 2-hydroxy-2-methyl-1-phenylpropan-1-one
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Chbb: HM-SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Purchased animals
- Age at study initiation: Not reported
- Weight at study initiation: 1.99 to 2.39 kg (mean weight of 2.19 kg)
- Fasting period before study: Not reported
- Housing: standard cages (manufactured by Becker) on metal floor grids
- Diet (e.g. ad libitum): Brand-Purina mixed feed manufactured by Kraftfutterwerke GmbH, Wiesbaden-Schierstein branch ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Not reported
- Only females were used
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 27 ± 7
- Humidity (%): 52 ± 20
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Duration of treatment / exposure:
- Single dose administration
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 4 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
-Not rinsed
SCORING SYSTEM: Local changes in the area of application were assessed according to DRAIZE (1959).
Cornea:
A = degree of opacity
B = region
Iris:
A = severity of the irritation
Conjunctiva:
A = erythema
B = swelling
C = secretion
TOOL USED TO ASSESS SCORE: Not reported
The behavior and general condition of the animals, as well as the occurrence of any local changes, were checked daily for 7 days and were recorded. All of the rabbits were weighed prior to the beginning of the experiment and also twice a week during the experiment.
Pathologico-anatomical examinations were made only when rabbits dided during the trial period. It was not found necessary to sacrfice and dissect the surviving animals.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- degree of opacity
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.75
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- degree of opacity
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.25
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- degree of opacity
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Remarks:
- region
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- region
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- region
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Remarks:
- severity of the irritation
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- erythema
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- erythema
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- erythema
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Remarks:
- swelling
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.25
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Remarks:
- swelling
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Remarks:
- swelling
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Remarks:
- secretion
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- secretion
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- secretion
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Irritant / corrosive response data:
- In the test for primary irritation of the mucous membrane in rabbits, there was slight reversible irritation for as long as 2 days after application of the substance.
- Other effects:
- All of the rabbits were clinically normal. The body weight did not differ from rabbits of the same age that had not been treated. All of the animals survived the 7-day treatment period. It was not found necessary to sacrifice and dissect the surviving animals. Pathologico-anatomical examinations would have been made if any rabbits died during the trial period.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item was not found to be irritant to the eyes under the test conditions.
- Executive summary:
(Awaiting report as results table needs to be sorted)
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